Trial Outcomes & Findings for Cast vs. Splints for Minimally Displaced Distal Radius Fractures in the Elderly (NCT NCT02066857)
NCT ID: NCT02066857
Last Updated: 2017-05-24
Results Overview
Wrist ROM will be assessed by a goniometer exam.
COMPLETED
NA
5 participants
Baseline, Month 3
2017-05-24
Participant Flow
Participants were recruited from the Emory Orthopaedic Fracture Clinic from April 2014 to November 2014.
Participant milestones
| Measure |
Generic Plaster or Fiberglass Cast Group
Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
|
Generic "Off the Shelf" Removable Splint Group
Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
4
|
|
Overall Study
COMPLETED
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cast vs. Splints for Minimally Displaced Distal Radius Fractures in the Elderly
Baseline characteristics by cohort
| Measure |
Generic Plaster or Fiberglass Cast Group
n=1 Participants
Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
|
Generic "Off the Shelf" Removable Splint Group
n=4 Participants
Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: Data for this outcome measure are not available for analysis.
Wrist ROM will be assessed by a goniometer exam.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 12Population: Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.
The Mayo Wrist Score is a clinician-completed scoring system used to evaluate the level of functionality in the wrist, assessing pain, functional status (able to work), range of motion and grip strength. Total scores for functionality range from 0-100 and are categorized as follows: 90-100 indicates excellent, 80-90 indicates good, 60-80 indicates satisfactory, below 60 indicates poor. The assessment was completed at all study visits.
Outcome measures
| Measure |
Generic Plaster or Fiberglass Cast Group
n=3 Participants
Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
|
Generic "Off the Shelf" Removable Splint Group
Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.
|
|---|---|---|
|
Mean Mayo Wrist Score
Baseline
|
31.67 units on a scale
Standard Deviation 16.07
|
—
|
|
Mean Mayo Wrist Score
Week 2
|
46.67 units on a scale
Standard Deviation 20.21
|
—
|
|
Mean Mayo Wrist Score
Week 6
|
65 units on a scale
Standard Deviation 10
|
—
|
|
Mean Mayo Wrist Score
Week 12
|
78.33 units on a scale
Standard Deviation 2.89
|
—
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: Data for this outcome measure are not available for analysis.
Grip strength will be assessed by bilateral dynamometer testing.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Duration of Study (Up to 3 Months)Population: Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.
The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction.
Outcome measures
| Measure |
Generic Plaster or Fiberglass Cast Group
n=3 Participants
Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
|
Generic "Off the Shelf" Removable Splint Group
Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.
|
|---|---|---|
|
Complication Rate
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 12Population: Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.
Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing "no pain" and 10 representing "the worst pain imaginable". The assessment was completed at all study visits.
Outcome measures
| Measure |
Generic Plaster or Fiberglass Cast Group
n=3 Participants
Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
|
Generic "Off the Shelf" Removable Splint Group
Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.
|
|---|---|---|
|
Mean Pain Score
Baseline
|
6 units on a scale
Standard Deviation 3.46
|
—
|
|
Mean Pain Score
Week 2
|
3.66 units on a scale
Standard Deviation 3.06
|
—
|
|
Mean Pain Score
Week 6
|
1.67 units on a scale
Standard Deviation 1.53
|
—
|
|
Mean Pain Score
Week 12
|
.33 units on a scale
Standard Deviation .58
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 12Population: Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.
The DASH questionnaire asks about symptoms as well as ability to perform certain activities. Scores range on a 0-100 scale. A higher score indicates greater disability.
Outcome measures
| Measure |
Generic Plaster or Fiberglass Cast Group
n=3 Participants
Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
|
Generic "Off the Shelf" Removable Splint Group
Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.
|
|---|---|---|
|
Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score
Baseline
|
73.03 units on a scale
Standard Deviation 23.53
|
—
|
|
Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score
Week 2
|
38.63 units on a scale
Standard Deviation 27.11
|
—
|
|
Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score
Week 6
|
23.33 units on a scale
Standard Deviation 22.50
|
—
|
|
Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score
Week 12
|
11.67 units on a scale
Standard Deviation 16.07
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: No participants completed this survey as this outcome measure was removed from the protocol. No data were collected.
The SF-12 QOL is a self-administered measure asking views about participant's health and how well they are able to perform usual activities.
Outcome measures
Outcome data not reported
Adverse Events
Generic Plaster or Fiberglass Cast Group
Generic "Off the Shelf" Removable Splint Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place